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An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study

Study Purpose

This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participant is treated with bevacizumab at the end of the Roche/Genentech sponsored parent trial and continues to have benefit as judged by the investigator.
  • - Eligible for continuation of bevacizumab treatment at the end of a parent trial, according to parent trial protocol.
  • - Able to comply with this extension study protocol (MO25757)

    Exclusion Criteria:

    - Evidence of disease progression assessed according to parent trial protocol during the screening phase for this extension study.
  • - Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation.
  • - A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the parent trial.
- Evidence of any other disease that would put the participant at high risk for treatment-related complications

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01588184
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries Austria, Brazil, Bulgaria, Canada, Czechia, Estonia, France, Germany, Hungary, Italy, Korea, Republic of, Mexico, Netherlands, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Turkey, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neoplasms
Arms & Interventions

Arms

Experimental: Breast Cancer

Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Experimental: Ovarian Cancer or Peritoneal Carcinoma

Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Experimental: Renal Cell Carcinoma

Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Experimental: Colorectal Cancer

Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Experimental: Non-Squamous, Non-Small Cell Lung Cancer

Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Experimental: Glioblastoma Multiforme

Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Interventions

Drug: - Bevacizumab

Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

A.Ö. LKH; Abt. für Lungenkrankheiten, Steyr, Austria

Status

Address

A.Ö. LKH; Abt. für Lungenkrankheiten

Steyr, , 4400

Goiania, GO, Brazil

Status

Address

Hospital Araujo Jorge; Departamento de Ginecologia E Mama

Goiania, GO, 74605-070

Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil

Status

Address

Hospital Sao Lucas - PUCRS

Porto Alegre, RS, 90610-000

Hospital de Cancer de Barretos, Barretos, SP, Brazil

Status

Address

Hospital de Cancer de Barretos

Barretos, SP, 14784-400

Sao Paulo, SP, Brazil

Status

Address

Instituto do Cancer do Estado de Sao Paulo - ICESP

Sao Paulo, SP, 01246-000

Hospital Perola Byington, Sao Paulo, SP, Brazil

Status

Address

Hospital Perola Byington

Sao Paulo, SP, 01317-000

Hospital A. C. Camargo; Oncologia, Sao Paulo, SP, Brazil

Status

Address

Hospital A. C. Camargo; Oncologia

Sao Paulo, SP, 01509-010

Hospital Sao Jose, São Paulo, SP, Brazil

Status

Address

Hospital Sao Jose

São Paulo, SP, CEP 01321-001

MBAL Serdika EOOD, Sofia, Bulgaria

Status

Address

MBAL Serdika EOOD

Sofia, , 1632

Toronto, Ontario, Canada

Status

Address

University Health Network; Princess Margaret Hospital; Medical Oncology Dept

Toronto, Ontario, M5G 2M9

Olomouc, Czechia

Status

Address

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, , 779 00

Tallinn, Estonia

Status

Address

North Estonia Medical Centre Foundation; Oncology Center

Tallinn, , 13419

HOPITAL JEAN MINJOZ; Oncologie, Besancon, France

Status

Address

HOPITAL JEAN MINJOZ; Oncologie

Besancon, , 25030

Centre Leonard De Vinci;Chimiotherapie, Dechy, France

Status

Address

Centre Leonard De Vinci;Chimiotherapie

Dechy, , 59187

Dijon, France

Status

Address

Centre Georges François Leclerc; Service Pharmacie, Bp 77980

Dijon, , 21000

Lille, France

Status

Address

Hopital Roger Salengro; Service de Neurologie

Lille, ,

Lyon, France

Status

Address

Centre Leon Berard; Departement Oncologie Medicale

Lyon, , 69373

Centre Paul Strauss; Oncologie Medicale, Strasbourg, France

Status

Address

Centre Paul Strauss; Oncologie Medicale

Strasbourg, , 67065

Hopital Larrey; Pneumologie, Toulouse, France

Status

Address

Hopital Larrey; Pneumologie

Toulouse, , 31059

Frankfurt am Main, Germany

Status

Address

Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie

Frankfurt am Main, , 60528

LungenClinic Großhansdorf GmbH, Großhansdorf, Germany

Status

Address

LungenClinic Großhansdorf GmbH

Großhansdorf, , 22927

Budapest, Hungary

Status

Address

Orszagos Onkologiai Intezet; Nogyogyaszati Osztaly

Budapest, , 1122

Napoli, Campania, Italy

Status

Address

A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica

Napoli, Campania, 80131

Bologna, Emilia-Romagna, Italy

Status

Address

Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

Bologna, Emilia-Romagna, 40138

Roma, Lazio, Italy

Status

Address

Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

Roma, Lazio, 00152

Milano, Lombardia, Italy

Status

Address

Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

Milano, Lombardia, 20133

Milano, Lombardia, Italy

Status

Address

Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

Milano, Lombardia, 20141

ASST DI MONZA; Oncologia Medica, Monza, Lombardia, Italy

Status

Address

ASST DI MONZA; Oncologia Medica

Monza, Lombardia, 20900

ASST LARIANA; Oncologia, S. Fermo Della Battaglia (CO), Lombardia, Italy

Status

Address

ASST LARIANA; Oncologia

S. Fermo Della Battaglia (CO), Lombardia, 22020

Torino, Piemonte, Italy

Status

Address

Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia

Torino, Piemonte, 10126

Brindisi, Puglia, Italy

Status

Address

Ospedale Antonio Perrino; Oncologia Medica

Brindisi, Puglia, 72100

Catania, Sicilia, Italy

Status

Address

Centro Catanese Di Oncologia; Oncologia Medica

Catania, Sicilia, 95126

Lido Di Camaiore, Toscana, Italy

Status

Address

Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica

Lido Di Camaiore, Toscana, 55043

Pisa, Toscana, Italy

Status

Address

A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

Pisa, Toscana, 56124

Prato, Toscana, Italy

Status

Address

Ospedale Misericordia E Dolce; Oncologia Medica

Prato, Toscana, 59100

National Cancer Center; Medical Oncology, Gyeonggi-do, Korea, Republic of

Status

Address

National Cancer Center; Medical Oncology

Gyeonggi-do, , 410-769

Severance Hospital; Internal Medicine, Seoul, Korea, Republic of

Status

Address

Severance Hospital; Internal Medicine

Seoul, , 110-744

Seoul, Korea, Republic of

Status

Address

Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

Seoul, , 138-736

Distrito Federal, Mexico

Status

Address

Instituto Nacional de Cancerologia; Oncology

Distrito Federal, , 14080

Leon, Mexico

Status

Address

Fundación Rodolfo Padilla Padilla, A.C.; Oncology

Leon, , 37000

Oaxaca Site Management Organization, Oaxaca, Mexico

Status

Address

Oaxaca Site Management Organization

Oaxaca, , 68000

Leyenburg Hospital; Pulmonology, Den Haag, Netherlands

Status

Address

Leyenburg Hospital; Pulmonology

Den Haag, , 2504 LN

Radboud Ziekenhuis; Urologie, 659, Nijmegen, Netherlands

Status

Address

Radboud Ziekenhuis; Urologie, 659

Nijmegen, , 6525 GA

Cluj Napoca, Romania

Status

Address

Prof. Dr. I. Chiricuta Institute of Oncology

Cluj Napoca, , 400015

Euroclinic Center of Oncology SRL, Iasi, Romania

Status

Address

Euroclinic Center of Oncology SRL

Iasi, , 700106

Barnaul, Russian Federation

Status

Address

Altai Region Oncology Dispensory; Oncology

Barnaul, , 656049

Regional Oncology Hospital; Oncology, Irkutsk, Russian Federation

Status

Address

Regional Oncology Hospital; Oncology

Irkutsk, , 664035

Moscow, Russian Federation

Status

Address

Blokhin Cancer Research Center; Combined Treatment

Moscow, , 115478

Moscow, Russian Federation

Status

Address

Russian Research Center of Roentgenoradiology; Dept of Chemotherapy

Moscow, , 117837

Moscow, Russian Federation

Status

Address

P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept

Moscow, , 125284

City Clinical Oncology Hospital, Moscow, Russian Federation

Status

Address

City Clinical Oncology Hospital

Moscow, , 143423

Obninsk, Kaluzhskaya Region, Russian Federation

Status

Address

Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease

Obninsk, Kaluzhskaya Region, , 249034

UFA, Russian Federation

Status

Address

Bashkirian Republican Clinical Oncology Dispensary

UFA, , 450054

Vychodoslovensky onkologicky ustav, Košice, Slovakia

Status

Address

Vychodoslovensky onkologicky ustav

Košice, , 040 01

Parktown, Johannesburg, South Africa

Status

Address

Wits Donald Gordon Clinical Trial Centre; Medical Oncology

Parktown, Johannesburg, , 2193

Bilbao, Vizcaya, Spain

Status

Address

Hospital de Basurto; Servicio de Oncologia

Bilbao, Vizcaya, 48013

Bilbao, Vizcaya, Spain

Status

Address

Hospital de Cruces; Servicio de Oncologia

Bilbao, Vizcaya, 48903

Burgos, Spain

Status

Address

Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

Burgos, , 09006

Hospital Reina Sofia; Medical Oncology, Cordoba, Spain

Status

Address

Hospital Reina Sofia; Medical Oncology

Cordoba, , 14004

Jaen, Spain

Status

Address

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

Jaen, , 23007

La Coruña, Spain

Status

Address

Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

La Coruña, , 15006

Hospital Gregorio Marañon, Madrid, Spain

Status

Address

Hospital Gregorio Marañon

Madrid, , 28007

Madrid, Spain

Status

Address

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, , 28041

Madrid, Spain

Status

Address

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, , 28046

Malaga, Spain

Status

Address

Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

Malaga, , 29010

Valencia, Spain

Status

Address

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Valencia, , 46010

Eskilstuna, Sweden

Status

Address

Mälarsjukhuset, Eskilstuna, Kvinnokliniken

Eskilstuna, , 63188

Umeå, Sweden

Status

Address

Norrlands universitetssjukhus; Onkologkliniken

Umeå, ,

Örebro, Sweden

Status

Address

Universitetssjukhuset Örebro, Onkologiska kliniken

Örebro, , 701 85

Adana City Hospital, Medical Oncology, Adana, Turkey

Status

Address

Adana City Hospital, Medical Oncology

Adana, , 01060

Cambridge, United Kingdom

Status

Address

Addenbrooke'S Hospital; Dept of Neurosurgery

Cambridge, , CB2 2QQ

Manchester, United Kingdom

Status

Address

Christie Hospital Nhs Trust; Medical Oncology

Manchester, , M2O 4BX

Rhyl, United Kingdom

Status

Address

North Wales Cancer Treatment Centre, Glan Clwyd Hospital

Rhyl, , LL18 5UJ